Conservative vs liberal fluid therapy in septic shock (CLASSIC)
trial-Protocol and statistical analysis plan

J 2019

Conservative vs liberal fluid therapy in septic shock (CLASSIC) trial-Protocol and statistical analysis plan

MEYHOFF, T.S., P.B. HJORTRUP, M.H. MOLLER, J. WETTERSLEV, T. LANGE et. al.

Basic information

Original name

Conservative vs liberal fluid therapy in septic shock (CLASSIC) trial-Protocol and statistical analysis plan

Authors

MEYHOFF, T.S. (guarantor), P.B. HJORTRUP, M.H. MOLLER, J. WETTERSLEV, T. LANGE, M.B.N KJR, A.B. JONSSON, C.J.S HJORTSO, M. CRONHJORT, J.H. LAAKE, S.M. JAKOB, M. NALOS, V. PETTIL, I. VAN DER HORST, M. OSTERMANN, P.. MOUNCEY, K. ROWAN, M. CECCONI, R. FERRER, M.L.N.G. MALBRAIN, C. AHLSTEDT, S. HOFFMANN, M.H. BESTLE, L. NEBRICH, L. RUSSELL, M. VANG, M.L. RASMUSSEN, C. SOLLING, B.S. RASMUSSEN, A.C. BROCHNER and A. PERNER

Edition

Acta Anaesthesiologica Scandinavica, HOBOKEN, WILEY, 2019, 0001-5172

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30230 Other clinical medicine subjects

Country of publisher

United States of America

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

CLASSIC

Impact factor

Impact factor: 2.050

RIV identification code

RIV/00216224:14110/19:00124330

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1111/aas.13434

UT WoS

000477274600001

Keywords (in Czech)

INTENSIVE;CARESEPSIS;PROTOCOL; MISSING DATA; RESUSCITATION; MANAGEMENT; MORTALITY; VOLUMES; ADULTS

Keywords in English

INTENSIVE;CARESEPSIS;PROTOCOL; MISSING DATA; RESUSCITATION; MANAGEMENT; MORTALITY; VOLUMES; ADULTS

Abstract

V originále

Introduction Intravenous (IV) fluid is a key intervention in the management of septic shock. The benefits and harms of lower versus higher fluid volumes are unknown and thus clinical equipoise exists. We describe the protocol and detailed statistical analysis plan for the conservative versus liberal approach to fluid therapy of septic shock in the Intensive Care (CLASSIC) trial. The aim of the CLASSIC trial is to assess benefits and harms of IV fluid restriction versus standard care in adult intensive care unit (ICU) patients with septic shock. Methods CLASSIC trial is an investigator-initiated, international, randomised, stratified, and analyst-blinded trial. We will allocate 1554 adult patients with septic shock, who are planned to be or are admitted to an ICU, to IV fluid restriction versus standard care. The primary outcome is mortality at day 90. Secondary outcomes are serious adverse events (SAEs), serious adverse reactions (SARs), days alive at day 90 without life support, days alive and out of the hospital at day 90 and mortality, health-related quality of life (HRQoL), and cognitive function at 1 year. We will conduct the statistical analyses according to a pre-defined statistical analysis plan, including three interim analyses. For the primary analysis, we will use logistic regression adjusted for the stratification variables comparing the two interventions in the intention-to-treat (ITT) population. Discussion The CLASSIC trial results will provide important evidence to guide clinicians' choice regarding the IV fluid therapy in adults with septic shock.

Links

90090, large research infrastructures

Name: CZECRIN II

Citovat

MEYHOFF, T.S., P.B. HJORTRUP, M.H. MOLLER, J. WETTERSLEV, T. LANGE, M.B.N KJR, A.B. JONSSON, C.J.S HJORTSO, M. CRONHJORT, J.H. LAAKE, S.M. JAKOB, M. NALOS, V. PETTIL, I. VAN DER HORST, M. OSTERMANN, P.. MOUNCEY, K. ROWAN, M. CECCONI, R. FERRER, M.L.N.G. MALBRAIN, C. AHLSTEDT, S. HOFFMANN, M.H. BESTLE, L. NEBRICH, L. RUSSELL, M. VANG, M.L. RASMUSSEN, C. SOLLING, B.S. RASMUSSEN, A.C. BROCHNER and A. PERNER. Conservative vs liberal fluid therapy in septic shock (CLASSIC) trial-Protocol and statistical analysis plan. Acta Anaesthesiologica Scandinavica. HOBOKEN: WILEY, 2019, vol. 63, No 9, p. 1262-1271. ISSN 0001-5172. Available from: https://dx.doi.org/10.1111/aas.13434.

@article{1837941,
   author = {Meyhoff, T.S. and Hjortrup, P.B. and Moller, M.H. and Wetterslev, J. and Lange, T. and Kjr, M.B.N and Jonsson, A.B. and Hjortso, C.J.S and Cronhjort, M. and Laake, J.H. and Jakob, S.M. and Nalos, M. and Pettil, V. and van der Horst, I. and Ostermann, M. and Mouncey, P.. and Rowan, K. and Cecconi, M. and Ferrer, R. and Malbrain, M.L.N.G. and Ahlstedt, C. and Hoffmann, S. and Bestle, M.H. and Nebrich, L. and Russell, L. and Vang, M. and Rasmussen, M.L. and Solling, C. and Rasmussen, B.S. and Brochner, A.C. and Perner, A.},
   article_location = {HOBOKEN},
   article_number = {9},
   doi = {http://dx.doi.org/10.1111/aas.13434},
   keywords = {INTENSIVE;CARESEPSIS;PROTOCOL; MISSING DATA; RESUSCITATION; MANAGEMENT; MORTALITY; VOLUMES; ADULTS},
   language = {eng},
   issn = {0001-5172},
   journal = {Acta Anaesthesiologica Scandinavica},
   note = {CLASSIC},
   title = {Conservative vs liberal fluid therapy in septic shock (CLASSIC) trial-Protocol and statistical analysis plan},
   url = {https://pubmed.ncbi.nlm.nih.gov/31276193/},
   volume = {63},
   year = {2019}
}

TY  - JOUR
ID  - 1837941
AU  - Meyhoff, T.S. - Hjortrup, P.B. - Moller, M.H. - Wetterslev, J. - Lange, T. - Kjr, M.B.N - Jonsson, A.B. - Hjortso, C.J.S - Cronhjort, M. - Laake, J.H. - Jakob, S.M. - Nalos, M. - Pettil, V. - van der Horst, I. - Ostermann, M. - Mouncey, P.. - Rowan, K. - Cecconi, M. - Ferrer, R. - Malbrain, M.L.N.G. - Ahlstedt, C. - Hoffmann, S. - Bestle, M.H. - Nebrich, L. - Russell, L. - Vang, M. - Rasmussen, M.L. - Solling, C. - Rasmussen, B.S. - Brochner, A.C. - Perner, A.
PY  - 2019
TI  - Conservative vs liberal fluid therapy in septic shock (CLASSIC) trial-Protocol and statistical analysis plan
JF  - Acta Anaesthesiologica Scandinavica
VL  - 63
IS  - 9
SP  - 1262-1271
EP  - 1262-1271
PB  - WILEY
SN  - 00015172
N1  - CLASSIC
KW  - INTENSIVE;CARESEPSIS;PROTOCOL
KW  - MISSING DATA
KW  - RESUSCITATION
KW  - MANAGEMENT
KW  - MORTALITY
KW  - VOLUMES
KW  - ADULTS
UR  - https://pubmed.ncbi.nlm.nih.gov/31276193/
N2  - Introduction Intravenous (IV) fluid is a key intervention in the management of septic shock. The benefits and harms of lower versus higher fluid volumes are unknown and thus clinical equipoise exists. We describe the protocol and detailed statistical analysis plan for the conservative versus liberal approach to fluid therapy of septic shock in the Intensive Care (CLASSIC) trial. The aim of the CLASSIC trial is to assess benefits and harms of IV fluid restriction versus standard care in adult intensive care unit (ICU) patients with septic shock. Methods CLASSIC trial is an investigator-initiated, international, randomised, stratified, and analyst-blinded trial. We will allocate 1554 adult patients with septic shock, who are planned to be or are admitted to an ICU, to IV fluid restriction versus standard care. The primary outcome is mortality at day 90. Secondary outcomes are serious adverse events (SAEs), serious adverse reactions (SARs), days alive at day 90 without life support, days alive and out of the hospital at day 90 and mortality, health-related quality of life (HRQoL), and cognitive function at 1 year. We will conduct the statistical analyses according to a pre-defined statistical analysis plan, including three interim analyses. For the primary analysis, we will use logistic regression adjusted for the stratification variables comparing the two interventions in the intention-to-treat (ITT) population. Discussion The CLASSIC trial results will provide important evidence to guide clinicians' choice regarding the IV fluid therapy in adults with septic shock.
ER  -

MEYHOFF, T.S., P.B. HJORTRUP, M.H. MOLLER, J. WETTERSLEV, T. LANGE, M.B.N KJR, A.B. JONSSON, C.J.S HJORTSO, M. CRONHJORT, J.H. LAAKE, S.M. JAKOB, M. NALOS, V. PETTIL, I. VAN DER HORST, M. OSTERMANN, P.. MOUNCEY, K. ROWAN, M. CECCONI, R. FERRER, M.L.N.G. MALBRAIN, C. AHLSTEDT, S. HOFFMANN, M.H. BESTLE, L. NEBRICH, L. RUSSELL, M. VANG, M.L. RASMUSSEN, C. SOLLING, B.S. RASMUSSEN, A.C. BROCHNER and A. PERNER. Conservative vs liberal fluid therapy in septic shock (CLASSIC) trial-Protocol and statistical analysis plan. \textit{Acta Anaesthesiologica Scandinavica}. HOBOKEN: WILEY, 2019, vol.~63, No~9, p.~1262-1271. ISSN~0001-5172. Available from: https://dx.doi.org/10.1111/aas.13434.

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